Regulation of Mucosal Immune Response to Systemic MenB Vaccine

NCT00774384 | Completed Phase 2

• 1 other identifier: SysVac01 - C60P2 PA/2008/2883
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

Meningitis or septicaemia (blood poisoning) caused by group B meningococcal infection (MenB) is an important cause of death and disability in the UK. Prevention through vaccination therefore remains a key public health priority. Research from national "meningitis" vaccine programmes against MenC, Hib and Streptococcus pneumoniae show us that their success is in part due to their ability to protect both the vaccinated and the unvaccinated, so-called herd immunity. This protection probably occurs by reducing carriage of these meningitis bacteria in the back of the throat (mucosal immunity). How this happens is poorly understood but our research shows that naturally acquired immunity (transient contact between the immune system and the meningococcus in the back of the throat without causing disease) may impact on this process. We believe that to develop a MenB vaccine that is able to cause mucosal immunity and prevent MenB carriage, it is important to understand the interaction between natural immunity and vaccination. In this study we propose to administer MenB vaccine to adults in order to investigate this process. Our findings will provide important insights into Men B immunity, inform the design of novel vaccine strategies and allow the rational testing of new vaccines as they become available.

Conditions

Meningococcal Infections

Keywords

Neisseria meningitidis; Mucosal; Vaccination; Immunity; T cells; T regulatory cells

Outcome Measures

Primary Outcomes (1)

• T-cell proliferation following vaccination and its regulation.

  After 2 or 3 doses of vaccine

Secondary Outcomes (3)

• Serum bactericidal antibody and OMV ELISA antibody.

  After each does of vaccine

• Salivary antibody

  After each dose of vaccine

• B-cell memory

  After 2 or 3 doses of vaccine

Study Arms (2)

1

ACTIVE COMPARATOR

Immunisation with NZ MenB OMV vaccine (NZ98/254)

Biological: NZ MenB OMV vaccine (NZ98/254)

2

NO INTERVENTION

No vaccine

Interventions

NZ MenB OMV vaccine (NZ98/254) BIOLOGICAL

3 doses by intramuscular injection

1

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• written informed consent and agreement for samples to be sent overseas
• adults and adolescents 16-40 years scheduled to undergo routine tonsillectomy
• in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator
• availability for all the visits scheduled in the study

You may not qualify if:

• tonsillectomy for allergic conditions
• receipt of or intent to immunize with any vaccination (other than influenza vaccine or post-exposure tetanus vaccination) or investigational agents within 50 days prior to enrolment and throughout the study period
• previous receipt of any MenB vaccine
• chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs (Inhaled and topical steroids will not be allowed.)
• history of confirmed or suspected meningococcal infection or close contact with an individual with culture or PCR proven N. meningitidis serogroup B within the previous 60 days
• pregnancy (or plans to become pregnant during study)\* or breast feeding
• not taking or unwilling to take sufficient measures to avoid pregnancy occurring for the duration of the study period\*\*
• any chronic or progressive disease (eg neoplasm, cardiac, respiratory, liver, gastrointestinal, renal, neurological disease, autoimmune disease, blood dyscrasias or diathesis) or history of dependence/abuse of drugs or alcohol • any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• administration of immunoglobulins and/or any blood products in the last year or planned administration during the study period
• history of any anaphylactic shock, asthma, urticaria or any other allergic reaction after previous vaccinations, or known hypersensitivity to any vaccine component
• fever (oral temperature equal to or greater than 38.5°C) within the past 24 hours or significant acute or chronic infection within the previous 7 days
• significant acute or chronic infections requiring systemic antibiotic treatment within the past 14 days
• not available for all the visits scheduled during the study period
• any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
• participation in another clinical trial within last 90 days or planned for during the study \* A pregnancy test (urine) on the scheduled day of each vaccination will be required for any female wishing to participate in the study as well as giving basic menstrual cycle information to cover the period in which and individual may be pregnant but this would not be ascertained by the chemical test.

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead
• University of Bristol: collaborator
• Public Health England: collaborator
• Novartis Vaccines: collaborator
• North Bristol NHS Trust: collaborator

Study Sites (2)

UBHT

Bristol, Avon, BS2 8HU, United Kingdom

Location

North Bristol NHS Trust

Bristol, Avon, United Kingdom

Location

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: September 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

GB (2)